Multiple Sclerosis (MS) is a debilitating chronic disease that affects millions of patients worldwide (Feigin et al.), in which the body’s own immune system attacks the central nervous system, causing irreversible damage that eventually leads to a slow but steady decline in mobility and life. 

In the last 20 years, MS treatment has been revolutionized, first with injectables and more recently with oral medications, including fumarates. Dimethyl fumarate (DMF) is currently the leading oral treatment for MS. 

 

However, its most common side effect (Bomprezzi 2015), flush, can cause discomfort and distress among patients and result in discontinuation and under-dosing (Sejbaek et al.). Aspirin has been used as a pre-treatment to reduce the Fumarate Flush. However, patients would have to take it at least 30 minutes before each administration and compliance has been poor. 

 

VTS-72: Novel Fumarate + VTS-Aspirin

for Relapsing-Remitting Multiple Sclerosis (RRMS)

VTS-72 aims to be the next generation oral fumarate therapy, that may hold potential as a treatment for RRMS with fewer side effects and other clinical benefits for these patients.

How Much Does Flush Matter?

As reported in the FDA approved labeling for DMF, in Phase III clinical trials, flush was the most common side effect, impacting 40% of patients

DMF Adverse Reactions Reported

240 mg BID ≥ 2% Higher Incidence Than Placebo

DMF

(n= 729)

Difference

DMF vs PLACEBO

Discontin-uation

3%

40%

34%

Flushing

Abdominal pain

18%

8%

4%

Diarrhea

14%

3%

24 months studies. Adapted from DMF FDA Approved Labeling: March 27, 2013

However, real-word DMF showed higher discontinuation rates

Post-marketing studies have shown the following:

 

VTS-72 Clinical Data

In a randomized, open-label, 2-way crossover study of 18 healthy subjects using the Global Flush Severity Scale (GFSS), subjects experienced a statistically significant average 63.3% less flush after VTS-72 than after standard dimethyl fumarate (DMF) (p=0.0018).

 

In addition, 39% of subjects who had experience flush with DMF reported absolutely no flush after VTS-72.

A pilot study suggests lower flush

© 2019 Vitalis, LLC

All Rights Reserved.

New York, NY

admin@vitalispharma.com